Radiographic and Inflammatory Biomarker Changes in Chronic Low Back Pain
- Conditions
- Low Back Pain
- Interventions
- Device: Virtual reality trainingDevice: Isokinetic trainingOther: Exercises
- Registration Number
- NCT05253599
- Lead Sponsor
- Prince Sattam Bin Abdulaziz University
- Brief Summary
OBJECTIVE: To find and compare the effects of isokinetic training and virtual reality training on pain intensity, trunk muscle strength, radiographical (muscle cross-sectional area and muscle thickness), and biochemical effects in chronic low back pain (LBP) patients.
- Detailed Description
OBJECTIVE: To find and compare the effects of isokinetic training and virtual reality training on pain intensity, trunk muscle strength, radiographical (muscle cross-sectional area and muscle thickness), and biochemical effects in chronic low back pain (LBP) patients.
METHODS: Randomized, double-blinded controlled study was conducted on 60 LBP patients and they were divided into isokinetic training (IKT; n=20), virtual reality training (VRT; n=20), and a control group (n=20). The VRT group received virtual training for core muscles of the trunk, the IKT group received training for trunk muscles through an Isokinetic dynamometer and the control group received conventional trunk balance exercises. Pain intensity (visual analog scale -VAS), trunk muscle strength, radiographical (muscle cross-sectional area through Magnetic resonance imaging - MRI \& muscle thickness through Ultrasound - US), and biochemical (CRP, TNF-α, IL-2, IL-4, IL-6) variables were measured at baseline and after 4 weeks (short term effect) of training.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
- University male football players
- Age group of 18 - 25 years
- chronic (≥3 months) LBP,
- 4 to 8 pain intensity in visual analog scale (VAS).
- Participants with severe musculoskeletal, neural, somatic, and psychiatric conditions,
- Waiting for spine surgery,
- Having alcohol or drug abuse,
- Involved in other weight and balance training programs.
- Participants with other soft tissue injuries, fractures in the lower limbs and pelvic bone, deformities.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual reality training Virtual reality training The VRT group received virtual reality training with (Pro-Kin system PK 252 N Techno body, Pelvic Module balance trunk MF, Italy) focusing on the balance of core stability muscles. Isokinetic training Isokinetic training In the IKT group before isokinetic training, the subjects were asked to perform five minutes' warm-up followed by slow stretching of back extensors and flexors. The subject was asked to be in an isokinetic dynamometer (Biodex Corporation, New York, USA) in a vertical standing position. Control group Exercises The Control group focused on conventional balance training for core muscles. The training includes active isotonic and isometric exercise for abdominal muscles (Internal oblique, external oblique, transverse abdominus and Rectus abdominus) deep abdominal muscles (Psoas major, Psoas minor, Illiacus and Quadratus Lumborum) and back muscles (Erector spinae, Transverses spinalis, inter spinalis and Inter transverse).
- Primary Outcome Measures
Name Time Method Pain Intensity After 4 weeks The pain intensity was measured by visual analog scale (VAS) which consist of a 10 cm horizontal line representing one end with "no pain at all" and the other end with "as bad as possible it could be." Each subject was asked to enter in the line as per his pain perception at rest and the score was measured by the distance on the line. The reliability and validity of VAS in application of musculoskeletal conditions was good.
Trunk flexor & extensor muscle strength After 4 weeks The trunk flexor and extensor muscles' peak torque was measured by using isokinetic dynamometer. The participant was positioned in standing position and wrapped the lower extremities with Velcro straps to prevent trick movements. Three measurements were taken at 900 per second for trunk flexors and extensors and the average value was considered for data analysis. The reliability and validity of this method of application in low back pain condition was good.
- Secondary Outcome Measures
Name Time Method Para spinal CSA Baseline and after 4 weeks Cross sectional area (CSA) is an area exposed by cut through at right angles to an axis. T2 weighted images of para spinal muscles (PM: Psoas Major, QL: Quadratus Lumborum, Mf: Multifidus and ES: Erector Spinae) CSA were taken using a 3-T MRI-scanner (Closed MRI system, Siemens, Hamburg, Germany) with a slice thickness of 5 mm. The subjects were placed in a supine position with a pillow kept under the knees to maintain the normal lordosis of the lumbar spine. The CSA at the level of L3-L4 was selected because of their maximal size at this level.
Muscle thickness Baseline and after 4 weeks Muscle size is considered as the thickness of muscle and the thickness of Multifidus muscle was measured by the diagnostic ultrasound device (Hitachi Ultrasound, Tokyo, Japan) which is the most reliable and valid method of measurement. The thickness of multifidus was taken from the left and right side of the L4 and L5 level. The subject lies in a prone position with a pillow under the abdomen to maintain lordosis. The thickness of the muscle was measured by measuring the distance between the most superficial portion of the facet joint and the plane between the muscle and the skin.
Inflammatory Biomarker Baseline and after 4 weeks Subject's blood samples of 10 ml were taken in sterile tubes between 08:00 - 10:00 am. Serum was separated and centrifuged, which was frozen at -700 C and stored. Serum levels of CRP, TNF-α, IL-2, IL-4, IL-6 were measured by enzyme-linked immunosorbent assay (ELISA) technique. The kit was used according to the guidelines of the manufacturer. The lower and upper limits of detection were computed for each assay, and the average percentages of samples were reported for statistical analysis.
Trial Locations
- Locations (1)
Dr. Gopal Nambi
🇸🇦Al Kharj, Riyadh, Saudi Arabia